In surgery as mentioned there is provided a channel to the outer world through the body wall, a so-called stoma, through which faecal material, liquid, urine and/or gases are excreted. As it is not possible to control at will the excretion through such artificial stoma, it must be closed in some manner. It is often done by affixing a pouch or bag to collect the waste material excreted. The affixing of such pouch may be done by the aid of some adhesive which provides, at the same time, a seal between the body and the pouch ensuring that the waste material is not leaking out of the pouch.
To illustrate the anatomy of an artificial body opening of the kind referred to, and the position of a collecting pouch and a sealing gasket, reference is made to the drawing, showing schematically in section an artificial intestinal opening--the stoma--in the torso of a patient, together with a section of a sealing gasket and part of collecting pouch.
In the drawing, 1 is the epidermis, 2 corium and subcutis and 3 a layer of abdominal muscles. This is delimited from inner cavities of the body by mucous membranes and the like, such as peritoneum 4. An intestine 5 by a surgical operation has been led through the various tissues of the abdominal wall so as to form a stoma 6. It should be noted how stoma 6 is caused to protrude from the abdominal wall; this protrusion may be smaller and larger and is not always as long (perpendicularly to the abdominal wall) as shown in the drawing. The inner wall of the intestine 5 is covered by a mucous membrane 7 and it should be noted how mucous membrane 7 covers even the protruding part of the stoma and is pulled back and sutured to the epidermis so that the entire protruding stoma is covered with the intestinal mucous membrane. This mucous membrane is resistant to the intestinal fluids which are very agressive to normal skin (epidermis) and whereas the intestinal fluids do no harm to the intestinal mucous membrane, it is important to prevent them from coming into contact with epidermis 1.
The drawing also schematically shows part of a stoma pouch 12, normally of some plastic material such as polyethylene, to collect excretions from the intestine 5; as the pouch as such does not form any part of the present invention, only a part of its panel facing the abdomen is shown. The pouch may be replaced by some other closing means such as a plug. To provide a tight seal between the pouch and the abdominal wall, and also to protect the part of the epidermis surrounding the stoma, there may be provided a sealing gasket or washer 11 between the pouch 12 (or other closing means) and the abdominal wall. The present invention is concerned with material for the sealing washer or gasket 11. Provided it is properly made and affixed to the pouch, it will ensure that the intestinal waste is discharged into the pouch 12 with a minimum contact with the epidermis. However, in practice heretofore such contact is never completely avoided and skin-irritation caused by intestinal fluids is a constant burden on a large number of patients. It is a main object of the present invention to provide an improved sealing material for gasket or washer 11 which will ensure that the intestinal fluids do not come into contact with the epidermis (skin) of the patient.
Whereas it is widely recognized that a need exists for making a seal between the stoma device and the patient's torso in order to prevent the intestinal material collected in the stoma device from leaking out into the open, it has apparently not been realized that a second, and for the patient equally important, seal is required to prevent the intestinal material from coming into contact with the patient's skin. This applies both when the stoma is closed by a stoma pouch and when it is closed by a plug or similar device since in such cases there may well be a risk that intestinal fluids leak between the plug and parts of the body facing the plug.